Non-pegylated liposomal doxorubicin triple combination therapy

a combination therapy and non-pegylated technology, applied in the field of metastatic breast cancer treatment, can solve the problems of limited use of doxorubicin, patients suffering irreversible cardiotoxicity, and serious side effects of doxorubicin and sometimes life-threatening side effects

Inactive Publication Date: 2011-10-20
SOPHERION THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, doxorubicin is associated with serious and sometimes life threatening side effects.
In particular, doxorubicin's use is limited by the potential for patients to suffer irreversible cardiotoxicity.
Clinically relevant cardiotoxicity has been a particular issue in combination regimens of doxorubicin and the taxanes, especially paclitaxel, and to a lesser extent docetaxel and albumin-bound paclitaxel (Abraxan®).
Doxorubicin and trastuzumab are known to be cardiotoxic, and their concomitant combined use presents a significant risk of cardiotoxicity.

Method used

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  • Non-pegylated liposomal doxorubicin triple combination therapy
  • Non-pegylated liposomal doxorubicin triple combination therapy

Examples

Experimental program
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Effect test

example 1

Preparation of Single Use Vial

[0048]Vial #1 Doxorubicin HCl for Injection is provided in glass vials sealed with butyl rubber stoppers and aluminum flip-off seals which contains:

Doxorubicin HCl, USP 50 mgLactose, NF (hydrous)250 mg

[0049]Vial #2 Liposomes for Injection is provided in 2 ml type I flint glass tubing vial with grey stoppers siliconized with dimethicone and a flip-off seal which contains:

Egg Phosphatidylcholine142.6 mgCholesterol, NF 57.4 mgCitrate Buffer (57.6 mg / mL) q.s.   2 mL

[0050]Vial #3 Buffer for Injection is provided in 5 ml type I molded glass vials with grey stoppers siliconized with dimethicone and a flip-off seal contains:

Sodium Carbonate anhydrous, NF54.6 mgWater for Injection, USP q.s. 3.1 mL

[0051]Each prepared vial of nonpegylated liposomal doxorubicin contains 50 mg of doxorubicin HCl, and each milliliter of nonpegylated liposomal doxorubicin contains:

Doxorubicin HCl 2.0 mgEgg phosphatidylcholine 5.4 mgCholesterol 2.2 mgCitric acid, monohydrate 4.4 mgSodi...

example 2

[0075]The following study is being conducted to evaluate the safety and efficacy of the combination of non-pegylated liposomal doxorubicin (MYOCET®), paclitaxel and trastuzumab as first-line treatment in patients with HER2-over-expressing metastatic breast cancer. Inclusion criteria for the study are: (1) metastatic HER2+ breast cancer by FISH analysis; (2) no prior chemotherapy for metastatic disease; (3) measurable disease; and (4) normal left ventricular ejection fraction. Exclusion criteria are: (1) prior doxorubicin treatment exceeding 300 mg / m2 or prior epirubicin treatment exceeding 600 mg / m2; and (2) relapse within 12 months of completion of adjuvant trastuzumab, taxane or anthracycline therapy.

[0076]The primary objectives of this trial are to demonstrate the efficacy and cardiac safety of Myocet® when given in combination with trastuzumab and paclitaxel in patients with HER2+ metastatic breast cancer.

[0077]Within the population of patients who are administered a dosing regi...

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Abstract

The present invention relates to a method for treating metastatic breast cancer in an individual comprising administering to an individual in need thereof a dosing regimen which comprises administering to the individual nonpegylated liposomal doxorubicin, a taxane and a HER2 / neu receptor antagonist, wherein the individual previously has been administered an anthracycline.

Description

RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Application Ser. No. 61 / 167,747, filed Apr. 8, 2009 and U.S. Provisional Application Ser. No. 61 / 294,712, filed Jan. 13, 2010, each of which is hereby incorporated by reference in its entirety.FIELD OF THE INVENTION[0002]The present invention is in the field of treatment for metastatic breast cancer in an individual who has previously been administered an anthracycline.BACKGROUND OF THE INVENTION[0003]Breast cancer is one of the most common causes of cancer deaths in women. In the United States, it accounts for 30% of all malignancies that affect women, excluding non-melanoma skin cancer. About one-third of newly diagnosed patients will eventually recur and / or develop metastatic disease.[0004]Approximately 25% of patients with breast cancer have tumors that over-express HER2. Data from large, international trials of adjuvant regimens for primary breast cancer in the pre-trastuzumab era have shown a sig...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/127A61P35/04A61K39/395
CPCA61K9/0019A61K9/127A61K47/26A61K39/39558A61K39/39533A61K31/704A61K31/7036A61K31/337A61K2300/00A61P35/00A61P35/04
Inventor ROZENCWEIG, MARCELGOLDFARB, RONALD H.FORENZA, SALVATORE
Owner SOPHERION THERAPEUTICS
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